FDA Orange Book
Generic for Inlyta
Inlyta contains axitinib. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
Yes. The generic name for Inlyta is axitinib. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Inlyta products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 1MG | Marketed (Rx) | AB | 1 | AB |
| tablet, oral | 5MG | Marketed (Rx) | AB | 1 | AB |
NDA 202324, held by PF PRISM CV. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic axitinib
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| APOTEX INC | 211650 | AB (A-rated, therapeutically equivalent) | October 30, 2025 | 1MG, 5MG |
Inlyta patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8791140 | December 14, 2030 | Drug substance | None | 202324 |
| 8791140*PED | June 14, 2031 | Method of use | None | 202324 |
| 12534530 | February 3, 2035 | Method of use | U-4411 | 202324 |
| 12534530 | February 3, 2035 | Method of use | U-4412 | 202324 |
| 10570202 | February 3, 2035 | Method of use | U-2844 | 202324 |
| 12534530*PED | August 3, 2035 | Method of use | None | 202324 |
| 10570202*PED | August 3, 2035 | Method of use | None | 202324 |
| 10869924 | January 12, 2037 | Method of use | U-3044 | 202324 |
| 10869924*PED | July 12, 2037 | Method of use | None | 202324 |
Inlyta NDC codes
Questions
Is there a generic for Inlyta?
Yes. The generic name for Inlyta is axitinib. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Inlyta?
The active ingredient in Inlyta is axitinib, per the FDA Orange Book.
When does the Inlyta patent expire?
The last patent listed for Inlyta in the Orange Book expires July 12, 2037. A listed patent expiry date is not a generic launch date.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.